VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Infections, Herpesviridae

Treatments: Drug: Placebo; Drug: Valaciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00116844

VLX103596

Details and patient eligibility

About

Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In overall general good health.
• HSV-2 (Herpes Simplex Virus-2) seropositive at screening.

Exclusion criteria

• have active lesions consistent with genital herpes.
• previous history of symptomatic genital herpes.
• history of recurrent, undiagnosed symptoms consistent with genital herpes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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73 participants in 2 patient groups

Sequence 1: VALTREX 1 g once daily, Placebo

Experimental group

Description:

VALTREX 1 g once daily, Placebo

Treatment:

Drug: Valaciclovir

Drug: Placebo

Sequence 2: Placebo, VALTREX 1 g once daily

Experimental group

Description:

Placebo, VALTREX 1 g once daily

Treatment:

Drug: Valaciclovir

Drug: Placebo